Events

Recall of SPIRIT BED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    105723
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The spirit plus and spirit select beds have actuators called the hi-lo actuators that allow for the bed to be raised and lowered. each bed has two actuators one that controls the headend of the bed's movement and one for the foot end. the actuators are mounted to the frame by use of a clevis pin design. the beds lower to a minimum height of 10.75 inches and a maximum height of 34 inches. it was identified that in some situations the actuator may break at the mount end.

Device

SPIRIT BED
  • Model / Serial
    Model Catalog: N3F02BCEF (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N2F00 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02BCEFMP196 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3FW2EM-06-06 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2F02BEMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2F02EM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3FY2YBEY (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F03BCEMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2F02E (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02CEP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02BCEMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2FY2YEY (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02CEFM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N3F02EFM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N3F03BCEFMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N3F02 (Lot serial: >10 NUMBERS CON
  • Product Description
    SPIRIT PLUS AND SPIRIT SELECT BED
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC